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Based on observation, staff interviews, and review of maintenance records on July 9, 2018, Chippewa Valley Hospital failed to construct, install and maintain the building systems to ensure life safety to patients.

42 CFR 485.623 Condition of Participation: Physical Environment was NOT MET

Findings include:

The facility was found to contain the following deficiencies.
K 293 exit signage;
K 345: fire alarm system-testing and maintenance;
K 363: corridor doors,
K 372: subdivision of building spaces-smoke barrier;
K 511: utilities-gas and electric;
K 920: electrical equipment-power cords and extensions;

Refer to the full description at the cited K tags.

The cumulative effect of environment deficiencies result in the Hospital's inability to ensure a safe environment for the patients.

Based on observation, staff interviews, and review of maintenance records on July 9, 2018, Chippewa Valley Hospital failed to construct, install and maintain the building systems to ensure life safety to patients.

42 CFR 485.623(d)(1) Condition of Participation: Safety from Fire was NOT MET

Findings include:

The facility was found to contain the following deficiencies.
K 293 exit signage;
K 345: fire alarm system-testing and maintenance;
K 363: corridor doors,
K 372: subdivision of building spaces-smoke barrier;
K 511: utilities-gas and electric;
K 920: electrical equipment-power cords and extensions;

Refer to the full description at the cited K tags.

The cumulative effect of environment deficiencies result in the Hospital's inability to ensure a safe environment for the patients.

34337

Based on observation, record review and interview, facility staff failed to discard expired medications, failed to correctly identify and label single use medication vials, and failed to discard single use vials after use in 1 of 3 patient care areas (Surgical Services). Failure to prevent multiple or subsequent medication administration of medications from single dose vials has the potential to affect all 14 patients scheduled to receive surgical services at the time of the survey.

Findings include:

Facility staff failed to remove or dispose of expired medications in 1 of 3 patient care areas. See tag C276.

Facility staff failed to discard single use vials after use in 1 of 3 patient care areas (Surgical Services). See tag C278.

Immediate Jeopardy was determined on 7/10/2018 at 9:40 AM regarding the failure to ensure single use medication vials are not available for use on multiple patients. The facility was notified of the Immediate Jeopardy on 7/10/2018 at 10:10 AM. The Immediate Jeopardy was removed on 7/10/2018 at 1:25 PM after removing all opened, unusable single use vials and providing a plan of correction that included the immediate education of nursing and pharmacy staff and labeling all single use vials as single use only with a bright color label. Deficient practice remains at the condition-level as the facility was unable to immediately implement a plan for sustainable and systemic corrections.

34337

Based on observation, record review and interview, the facility failed to ensure expired medications were not available for patient use in 1 of 3 patient care areas observed (Surgical Services).

Findings include:

Review of facility policy "Procedure for Checking Outdates" dated 12/2017 revealed "At the end of every month the pharmacy tech will check medications at the nurses station, emergency room and OR [Operating Room] for outdates and replace them."

Review of facility policy "Multidose Vials" dated 12/2017 revealed "Multidose vials have to be dated when opened and can be used for a length of 28 days unless otherwise recommended by the manufacturer, as long as they contain preservatives and are labeled for the date the vial is opened. ...The vial should be discarded if there is any suspicion of is being compromised or contaminated. these vials must be dated when opened and discarded according to manufacturer recommendations."

During observation of the Surgical Department on 7/9/2018 at 1:45 PM, the operating room anesthesia cart contained an opened multidose vial of labetolol dated 6/8/2018, an opened multidose vial of dexamethasone with an unreadable open date, and an unopened vial of epinephrine with a manufacturer expiration date of 6/1/2018. The malignant hyperthermia cart contained 9 bags of sterile water with a manufacturer expiration date of 6/2018.

During an interview at the time of the observation, Surgical Services Manager G stated "pharmacy comes in once a month to review the medications for outdates." Per G, the opened vials of medications "are only good for 28 days" after opening and should be disposed if more than 28 days old or the date is unable to be determined. Manager G stated the sterile water "has been on back order, we have some in now" but the stock had not been replaced.

34337

Based on observation, record review and interview, facility staff failed to ensure unsafe and potentially contaminated single use medications are not available for patient use for 14 of 14 patients scheduled to receive surgical services at the facility (Patients #21, #22, #23, #24, #25, #26, #27, #28, #29, #30, #31, #32, #33, #34).

Findings include:

During observation of the operating room suite on 7/9/2018 at 1:30 PM, the anesthesia cart contained an opened vial of 0.9% sodium chloride dated 6/27/2018. Review of the manufacturer label on the vial revealed "Single-dose... preservative free." During an interview at the time of the observation, when asked about the opened, single dose vial, Surgical Services Manager G stated "The CRNA [Certified Registered Nurse Anesthetist] and pharmacy take care of the medications in the anesthesia cart, I don't go in there."

During observation in the anesthesia office on 7/9/2018 at 1:40 PM, the office cabinet contained an opened, single dose vial of Chloroprocaine 2% dated 6/27/2018. During an interview at the time of the observation, Manager G stated "I don't know why that's in there, you'd have to ask [CRNA I] about that."

During an interview on 7/10/2018 at 9:05 AM, when asked about the opened, single use vial of Chloroprocaine 2%, CRNA I stated "I threw that away, it shouldn't have been in there." CRNA I went on to state "It was used on a patient, and then I brought it back to the office. It shouldn't have been brought back here, I don't know why I did that."

Review of the manufacturer description and instructions for 0.9% Sodium Chloride revealed "It contains no bacteriostat, antimicrobial agent or added buffer and is supplied only single-dose containers... contains no preservatives. ...Do not reuse single-dose containers, discard unused portion."

Review of the manufacturer description and instructions for Chloroprocaine Hydrochloride Injection revealed "...in single dose vials, without [preservative]..."

An interview was conducted on 7/10/2018 at 9:15 AM with CRNA I, Pharmacist K and Pharmacy Technician L. Regarding the procedures for single dose vials, Pharmacist K stated "they aren't good after they are used. They should be used once and disposed immediately." The opened, dated vial of 0.9% sodium chloride was observed in the operating room at the time of the interview. The single dose vial had a sticker label with space to document the date opened with "Discard within 28 days" on the label. The anesthesia cart contained an additional, unopened vial of 0.9% sodium chloride with the same sticker label. Pharmacy Technician L stated the stickers are put on the vials by the pharmacy technicians prior to going to the operating room. When asked why a label stating "discard within 28 days" was placed on a single use vial, L stated "I don't know."

During an interview on 7/10/2018 at 9:20 AM, when asked if the opened single use vial of sodium chloride would have been used for any patients, CRNA stated "possibly."

During an interview on 7/10/2018 at 9:20 AM, when asked about the potential risks for patients receiving medication from a single dose vial that had been opened on 6/27/2018, Pharmacist K stated "the vial is preservative free, so there's a risk of microbial growth" which could cause "shock, sepsis and death" for the patient.

During an interview on 7/9/2018 at 1:15 PM, Surgical Services Manager G stated the facility had no patients scheduled for surgeries or procedures on 7/9/2018 or 7/10/2018. Review of the surgery case schedule for the week of 7/9/2018 revealed the following scheduled surgical patients: 1 patient (Patient #21) on 7/11/2018; 2 patients (Patient #22, Patient #23) on 7/12/2018; and 11 patients (Patient #24, Patient #25, Patient #26, Patient #27, Patient #28, Patient #29, Patient #30, Patient #31, Patient #32, Patient #33 and Patient #34) on 7/13/2018.

Based on observation, record review and interview, facility staff failed to develop a system for tracking use and disinfection for 6 of 6 endoscopes (Scope #1 - Scope #6); failed to use immediate use sterilization per policy and manufacturer recommendations for 1 of 6 surgical specialties (Ophthalmology); failed to identify discharge criteria per physician orders for 5 of 5 patients (Patient #16, Patient #17, Patient #18, Patient #19, Patient #20); and failed to minimize surgical fire risk by documenting skin preparation solution dry time for 3 of 3 patients (Patient #16, Patient #18, Patient #19).

Findings include:

Endoscope Reprocessing

Review of facility policy "Cleaning and Maintenance of Endoscopes" dated 6/2018 did not include expectations for the frequency of endoscope reprocessing during times of non-use or a system for tracking the use and disinfection of the endoscopes.

During observation of the Endoscopy Room on 7/9/2018 at 1:45 PM, the endoscope cabinet contained 6 tubes. During an interview at the time of the observation, Surgical Technician H stated "We have 3 gastric scopes and 3 colonoscopes... we usually do endoscope procedures about twice a month." H stated there was no documentation of which scopes were disinfected and when. Per H, "all the scopes are cleaned on days when we do scope [procedures], even if they aren't used." H was unable to provide a log or documentation. When asked how the facility tracks which scope was used on which patient and when, Surgical Services Manager G stated "the physician makes note of which scope is used in their [Operative] report, but we don't keep track of that anywhere else." G stated the facility follows AORN (Association of Peri-Operative Registered Nurses) and AAMI (Association for the Advancement of Medical Instrumentation) guidelines. Per G, "it's recommended to track and document [scope use and disinfection] but our policy doesn't address that."

Immediate Use Steam Sterilization

Review of facility policy "Flash Sterilizer" dated 2/2018 revealed "Flash sterilization should only be used for the emergency sterilization of clean, unwrapped instruments and porous items only; it should only be used when time does not permit sterilizations by the preferred wrapped method."

During an interview on 7/9/2018 at 1:30 PM, Surgical Technician H stated the facility uses immediate use steam sterilization "about once a month, on eye day." Review of the facility's log revealed the immediate use steam sterilizer was used 8 times on 5/11/2018 and 9 times on 6/8/2018. Per H, "we usually have about 10 cases per day and we only have 2 eye instrument sets we flash sterilize them in between cases."

Review of the reprocessing instructions for the instruments typically sterilized for immediate use at the facility revealed "Warning: Flash sterilization processing should be reserved for emergency reprocessing only and should not be employed for routine sterilization processing of the instrument."

During an interview on 7/10/2018 at 8:00 AM, Surgical Services Manager G stated "we have a contract for performing cataract surgery, they [contracted company] provide us with 2 sets of equipment." Review of the contract, dated 12/1/2016, revealed "[Contracted company] shall purchase additional instrument trays, or individual instruments, at the request of the Customer." Manager G stated "we will have to look into our process."

Surgical Discharge Criteria

Review of facility policy "Pre & Post-op Care" dated 4/2018 revealed "Discharge criteria must be met and documented prior to D/C [discharge]."

Review of facility policy "Discharge of Patient" dated 4/2018 revealed "A physician's order is required for the discharge of all patients."

Per medical record review, Patient #16 was admitted for outpatient surgery on 7/3/2018. Patient #16's orders included "Discharge when discharge criteria met." The criteria for discharge was not specified in Patient #16's medical record.

Per medical record review, Patient #17 was admitted for outpatient surgery on 6/27/2018. Patient #17's orders included "Discharge when discharge criteria met." The criteria for discharge was not specified in Patient #17's medical record.

Per medical record review, Patient #18 was admitted for outpatient surgery on 6/8/2018. Patient #18's orders included "Discharge when discharge criteria met." The criteria for discharge was not specified in Patient #18's medical record.

Per medical record review, Patient #19 was admitted for outpatient surgery on 5/31/2018. Patient #19's orders included "Discharge when discharge criteria met." The criteria for discharge was not specified in Patient #19's medical record.

Per medical record review, Patient #20 was admitted for outpatient surgery on 7/2/2018. Patient #20's orders included "Discharge when discharge criteria met." The criteria for discharge was not specified in Patient #20's medical record.

During an interview on 7/9/2018 at 3:00 PM, when asked about the criteria that must be met prior to discharge, Surgical Services Manager G stated "there is criteria embedded into the electronic health record." Review of the procedure discharge criteria included a list of 24 specific outcomes and 1 criteria listed as "other." Per G, "the nurse picks the criteria that applies to the patient."

During an interview on 7/9/2018 at 3:25 PM, Registered Nurse J stated "it's okay to discharge [surgical patients] when their vital signs are stable, they are alert and oriented, moving their extremities and everything is the same as pre-op." Registered Nurse J stated the criteria was not specified by physician orders.

Surgical Services Manager G was unable to produce evidence that discharge criteria was ordered by the physician for the above patients. During an interview on 7/10/2018 at 8:05 AM, Manager G stated "there's general criteria but it's not specific to the patient or ordered by the physician."

Surgical Site Preparation

Review of facility policy "Skin Preparation" dated 2/2018 did not include recommendations for allowing skin preparation solutions to dry or documenting dry times.

Review of facility policy "Electrosurgery (Cautery)" dated 2/2018 revealed "D. Safety: 2. Prep solutions should not be allowed to pool under and around the patient... Excess prep should be blotted and sufficient time allowed for prep solutions to dry and vapors to dissipate and mix with room air prior to draping."

Per medical record review, Patient #16 was admitted on 7/3/2018 for a left knee arthroscopy. The skin preparation of betadine and Chloraprep were documented at 1:15 PM. There was no documentation that the prep solutions were dry prior to draping or prior to the start of surgery at 1:20 PM.

Per medical record review, Patient #18 was admitted on 6/8/2018 for a left eye cataract extraction. Skin preparation of betadine was documented as applied to the left eye at 12:22 PM, after the surgery start time of 12:21 PM.

Per medical record review, Patient #19 was admitted on 5/31/2018 for a laparoscopic cholecystectomy. Skin prep solution of Chloraprep was documented as applied to the abdomen area at 9:25 AM, after the surgery start time of 9:24 AM. There was no documentation that the prep solution was dry prior to draping or prior to the start of surgery.

During an interview on 7/10/2018 at 11:50 AM, Surgical Services Manager G stated "there's no place to document that in the EMR [electronic medical record]; we will have to address that."